Dihydropyridine Calcium Channel BlockerPrescription OnlyPregnancy Cat. CFDA Yes
Cleviprex
CLEVIDIPINE
1 INDICATIONS AND USAGE Cleviprex is indicated for the reduction of blood pressure when oral therapy is not feasible or not desirable. Cleviprex is a dihydropyridine calcium channel blocker indicated for the reduction of blood pressure when oral therapy is not feasible or not desirable. (1)
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Brand names:Cleviprex
Quick Reference
Medicine ClassDihydropyridine Calcium Channel Blocker
FDA ApprovedYes
PregnancyCategory C
Quick Facts
- Active ingredient
- CLEVIDIPINE
- Medicine class
- Dihydropyridine Calcium Channel Blocker
- Brand names
- Cleviprex
- Availability
- Prescription only (Rx)
- Pregnancy category
- C
- Half-life
- half life
- FDA approved
- Yes
What Is Cleviprex?
1 INDICATIONS AND USAGE Cleviprex is indicated for the reduction of blood pressure when oral therapy is not feasible or not desirable. Cleviprex is a dihydropyridine calcium channel blocker indicated for the reduction of blood pressure when oral therapy is not feasible or not desirable. (1)
Cleviprex (CLEVIDIPINE) belongs to the Dihydropyridine Calcium Channel Blocker class of medications. It was first approved by the FDA in Yes. This medication requires a prescription from a licensed healthcare provider.
Key Safety Information
- •Always follow the dose recommended by your healthcare professional. Taking more than prescribed increases the risk of side effects including serious complications.
- •Seek emergency care if you experience signs of an allergic reaction — hives, swelling, difficulty breathing, or rash. Stop the medication and call your doctor immediately.
- •Some medications can increase the risk of cardiovascular events. Tell your doctor if you have high blood pressure, a history of heart attack or stroke, or any pre-existing health condition.
- •Avoid or limit alcohol while taking Cleviprex. Do not drink alcohol without first discussing it with your healthcare provider as it may increase adverse effects.
- •Take Cleviprex with food or a full glass of water if stomach upset occurs. Stop use and talk to your doctor if you experience persistent stomach pain or GI symptoms.
- •Tell your doctor about all medications, supplements, and vitamins you take. Some combinations significantly increase the risk of harm.
This is a summary only. Always read the full prescribing information and consult your healthcare provider for personalized medical advice.
Uses & Indications
Cleviprex is prescribed for the following conditions. Some uses are FDA-approved indications; others may be evidence-based off-label uses. Consult your healthcare provider for personalized guidance.
1 INDICATIONS AND USAGE Cleviprex is indicated for the reduction of blood pressure when oral therapy is not feasible or not desirable.
Cleviprex is a dihydropyridine calcium channel blocker indicated for the reduction of blood pressure when oral therapy is not feasible or not desirable.
Dosage Guide
The following are general dosing guidelines only. Your actual dose should be determined by your healthcare provider based on your condition, renal/hepatic function, and other medications.
AD
Adult Dosage
2 DOSAGE AND ADMINISTRATION For intravenous use : Cleviprex is intended for intravenous use. Titrate Cleviprex to achieve the desired blood pressure reduction. Individualize dosage depending on the blood pressure response of the patient and the goal blood pressure. (2.2) Monitoring : Monitor blood pressure and heart rate during infusion, and until vital signs stabilize. (2.1) Initial dose : Initiate intravenous infusion of Cleviprex at 1- 2 mg/hour. (2.2) Dose titration : Double the dose at short (90 second) intervals initially. As the blood pressure approaches goal, increase the dose by less than doubling and lengthen the time between dose adjustments to every 5-10 minutes. An approximately 1-2 mg/hour increase will generally produce an additional 2-4 mmHg decrease in systolic pressure. (2.2) Maintenance dose : Most patients will achieve the desired therapeutic response at approximately 4-6 mg/hour. Severe hypertension is likely to require higher doses. (2.2) Maximum dose : Most patie
Available Forms
Available Strengths
Side Effects
Common
- 6 ADVERSE REACTIONS The following risk is discussed elsewhere in the labeling: Hypotension and Reflex Tachycardia [see Warnings and Precautions (5.2)] Most common adverse reactions (>2%) are headache, nausea, and vomiting.
- (6.1) To report SUSPECTED ADVERSE REACTIONS, contact The Medicines Company at 1-888-977-MDCO (6326) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
- 6.1 Clinical Trials Experience Cleviprex clinical development included 19 studies, with 99 healthy subjects and 1307 hypertensive patients who received at least one dose of clevidipine (1406 total exposures).
- Clevidipine was evaluated in 15 studies in hypertensive patients: 1099 patients with perioperative hypertension, 126 with severe hypertension and 82 patients with essential hypertension.
- The desired therapeutic response was achieved at doses of 4-6 mg/hour.
- Cleviprex was infused for <24 hours in the majority of patients (n=1199);
- it was infused as a continuous infusion in an additional 93 patients for durations between 24 and 72 hours.
Serious
- 5 WARNINGS AND PRECAUTIONS Maintain aseptic technique.
- Discard unused portion 12 hours after stopper puncture.
- (5.1) Hypotension and reflex tachycardia are potential consequences of rapid upward titration of Cleviprex.
- (5.2) Dihydropyridine calcium channel blockers can produce negative inotropic effects and exacerbate heart failure.
- Monitor heart failure patients carefully.
Rare
Medicine Interactions
Always inform your healthcare provider and pharmacist about ALL medications you take, including prescriptions, OTC medicines, vitamins, and supplements.
MajorModerateMinor
Warnings & Contraindications
5 WARNINGS AND PRECAUTIONS Maintain aseptic technique. Discard unused portion 12 hours after stopper puncture. (5.1) Hypotension and reflex tachycardia are potential consequences of rapid upward titration of Cleviprex. (5.2) Dihydropyridine calcium channel blockers can produce negative inotropic effects and exacerbate heart failure. Monitor heart failure patients carefully. (5.4) Cleviprex gives n
How Cleviprex Works
12.1 Mechanism of Action Clevidipine is a dihydropyridine L-type calcium channel blocker. L-type calcium channels mediate the influx of calcium during depolarization in arterial smooth muscle. Experiments in anesthetized rats and dogs show that clevidipine reduces mean arterial blood pressure by decreasing systemic vascular resistance. Clevidipine does not reduce cardiac filling pressure (pre-load), confirming lack of effects on the venous capacitance vessels.
Pharmacokinetics
Half-Life
half life
Metabolism
metabolized resulting in a very short half life
Pregnancy & Breastfeeding Safety
C
FDA Pregnancy Category C
Animal studies show adverse fetal effects. No adequate human studies. Use only if benefit justifies risk.
Full Pregnancy InformationBreastfeeding
Many medications pass into breast milk in varying amounts. Before using Cleviprexwhile breastfeeding, discuss the benefits and risks with your healthcare provider or pharmacist — they can weigh your dose, your infant's age, and available lactation safety data to find the safest option for you and your baby.
Storage & Handling
Storage Leave vials in cartons until use. Clevidipine is photosensitive and storage in cartons protects against photodegradation. Protection from light during administration is not required. Store vials refrigerated at 2-8°C (36-46°F). Do not freeze . Vials in cartons may be transferred to 25°C (77°
Frequently Asked Questions
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Cleviprex side effects
Complete adverse effect profile including common, serious, and rare reactions
Sources & References
- • FDA Prescribing Information — Official labeling and package insert for Cleviprex
- • U.S. National Library of Medicine — MedlinePlus drug information
- • American Hospital Formulary Service (AHFS) — Clinical pharmacology monograph
- • PubMed / MEDLINE — View clinical studies
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Medical Disclaimer
The information on this page is for educational purposes only and is not intended as medical advice, diagnosis, or treatment. Always consult your doctor, pharmacist, or qualified healthcare provider before starting, stopping, or changing any medication.